Biodexa, which has already received U.S. FDA Orphan Drug designation for eRapa in FAP, plans to seek a similar designation in Europe. eRapa is a proprietary oral tablet formulation of rapamycin ...
Ac-SSO110 has now received FDA orphan drug designation and investigational new drug application clearance for the treatment ...
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FDA grants orphan drug status to Arbor Biotechnologies’ PH1The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) and rare paediatric disease designation (RPDD) to Arbor Biotechnologies' gene editing therapeutic, ABO-101, to treat ...
"The Orphan Drug Designation not only acknowledges the critical need for new, effective treatments for HAE in Japan but underscores the potential of sebetralstat to provide meaningful relief for ...
Ensoma Inc.’s lead program, EN-374, has been granted orphan drug and rare pediatric disease designations by the FDA for the ...
has granted Orphan Drug Designation (ODD) to its proprietary radiopharmaceutical, 225Ac-satoreotide, for treating patients with Small Cell Lung Cancer (SCLC). SCLC is a severe condition with a poor ...
Orphan Drug and Rare Pediatric Disease designations follow U.S. FDA acceptance of IND application for ABO-101 for the treatment of PH1, with Phase 1/2 trial initiation anticipated in H1 2025.
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